BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLISENS® EASYMAG® MAGNETIC SILICA 384T

    MDR report key: 6004469 · Received October 6, 2016

    Report

    Report Number
    3002769706-2016-00375
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Report Date
    September 15, 2016
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    LDT
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    FSCA 3037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. RESULTS ARE AS FOLLOWS: A DIFFERENCE OF QUANTIFICATION UP TO 1 LOG AND SOMETIME MORE THAN 1 LOG WAS OBSERVED , WHICH CAN BE SIGNIFICANT ON RESULTS. AS THE DOWNSTREAM APPLICATIONS ARE QUALITATIVE AND/OR QUANTITATIVE METHODS, THE DECREASE IN PERFORMANCES IN DOWNSTREAM APPLICATION COULD LEAD TO: A RISK OF FALSE NEGATIVE, FOR QUALITATIVE TESTS. INVALID RESULTS, WHEN EXTRACTED AND AMPLIFIED INTERNAL CONTROL IS NOT WITHIN SPECIFICATIONS · UNDER-QUANTIFICATION FOR VIRAL LOAD RESULTS FOR QUANTITATIVE TESTS. DURING THE INVESTIGATION, WE CONFIRMED THE ISSUE FOR THE FOLLOWING SPECIFIC CUSTOMER'S APPLICATIONS: IMPACT WHEN USING A HIGH SAMPLE INPUT VOLUME, FROM 200¿L AND UP TO 1 ML. IMPACT WHEN DOUBLE STRANDED NUCLEIC ACID APPLICATIONS WITH SMALL (<40KBP) AND MEDIUM GENOME SIZES (<TO 1200 KBP) ARE SEARCHED WITH REAL TIME PCR ASSAYS- I.E. DNA VIRUSES, ARE MORE IMPACTED THAN HUMAN GENOMIC DNA AND BACTERIAL APPLICATIONS ( >TO 1200KBP) THE ROOT CAUSE HAS NOT YET BEEN IDENTIFIED. THE INVESTIGATION IS STILL ONGOING INTERNALLY. SINGLE STRANDED RNA VIRUS APPLICATIONS ARE NOT IMPACTED EXCEPTED IF THE RNA IS EXTRACTED WITHOUT MATRIX (E.G. IN WATER). NO SIGNIFICANT IMPACT HAS BEEN IDENTIFIED FOR THE IVD NUCLISENS AND ARGENE REAL TIME PCR KITS VALIDATED WITH THE EASYMAG AND THE MINIMAG EXTRACTION SYSTEMS. AS STATED IN THE EASYMAG USER MANUAL, THE USE OF AN INTERNAL CONTROL IS RECOMMENDED IN ORDER TO DETECT ANY POTENTIAL NUCLEIC ACID EXTRACTION ISSUE. THE DESIGN OF THE INTERNAL CONTROL HAS TO BE AS CLOSE AS POSSIBLE TO THE REQUESTED TARGET'S DESIGN IN ORDER TO BE MORE EFFICIENT. A FIELD SAFETY CORRECTIVE ACTION (FSCA) 3037 HAS BEEN ISSUED TO IMPACTED SUBSIDIARIES/DISTRIBUTORS TO NOTIFY AFFECTED CUSTOMERS OF THIS ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A DISCREPANT RESULT WHEN USING THE NUCLISENS MAGNETIC SILICA REAGENT. THE INTERNAL CONTROL OF THE ELUATE DID NOT PASS THE REQUIRED CUSTOMER CRITERIA. WHEN SPECIFICALLY ASKED, THE CUSTOMER INDICATED THAT NO DEATH, INJURY OR MISTREATMENT WAS ASSOCIATED WITH THIS ISSUE. THE CUSTOMER DID INDICATE A DELAY OF RESULTS OF AN INDETERMINATE AMOUNT OF TIME AS A RESULT OF NEEDING TO RERUN THE SAMPLES. BIOMERIEUX HAS INITIATED AN INVESTIGATION INTO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660437 NUCLISENS® EASYMAG® MAGNETIC SILICA 384T NUCLISENS® EASYMAG® MAGNETIC SILICA 384T LDT BIOMÉRIEUX SA Z017KG1MS

    Patients

    Seq Age Sex Outcome Treatment
    1